Measured Hypocretin Levels and Recovery After Hip Surgery

NCT01009710 | Unknown

• 2 other identifiers: SU-07162009-330116339
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

A specific group of neurons in the brain produces hypocretin, a peptide which has been established as an important regulator of sleep and wakefulness. Activation of these neurons (increased hypocretin) stabilizes wakefulness; impairing or blocking these neurons (decreased hypocretin) promotes sleep. Evidence suggests that these neurons may be involved in the hypnotic properties of several anesthetics, and play a role in the induction and emergence from anesthesia. In humans there is a considerable inter-individual variability in hypocretin levels. This study aims to investigate how hypocretin levels affect the anesthetic care and recovery of patients undergoing elective hip surgery.

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (1)

• Anesthetic Recovery Times

  recovery from anesthesia will be measured by short-term outcomes like time to tracheal extubation and response to verbal commands, as well as by psycho-vigilance testing up to 72 hours postoperatively

  0-72 hours after surgery

Secondary Outcomes (2)

• sensitivity to sevoflurane during inhalation induction to anesthesia, determined by bispectral index of the EEG

  during anesthetic induction

• pain and sleepiness

  from 0-72 hours after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective total hip arthroplasty through the Stanford Orthopedic Clinic.

You may qualify if:

• Male or female
• Scheduled for elective total hip arthroplasty at the Stanford Orthopedic Clinic.

You may not qualify if:

• Diagnosed psychiatric disease (except mild depression)
• Any diagnoses CNS disease or dementia
• History of stroke
• History of untreated thyroid disease
• Difficulty in airway management (ventilation and/or intubation)
• Body Mass Index (BMI) \> 35 kg/m2

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Anthony Doufas

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 9, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2018
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

US (1)